Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults



Status:Recruiting
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:November 14, 2018
End Date:November 30, 2020
Contact:Robert Berman
Email:clinicaltrials@biohavenpharma.com
Phone:203-404-0410

Use our guide to learn which trials are right for you!

A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention

The purpose of this is study is to compare the efficacy of BHV-3000 (rimegepant) to placebo
as a preventive treatment for migraine, as measured by the reduction in the number of
migraine days per month.


Inclusion Criteria:

1. Subject has at least 1 year history of migraine (with or without aura) consistent with
a diagnosis according to the International Classification of Headache Disorders, 3rd
Edition, including the following:

1. Age of onset of migraines prior to 50 years of age

2. Migraine attacks, on average, lasting 4 - 72 hours if untreated

3. Per subject report, 4 - 18 migraine attacks of moderate to severe intensity per
month within the last 3 months prior to the Screening Visit

4. 6 or more migraine days during the Observation Period

5. Not more than 18 headache days during the Observation Period

6. Ability to distinguish migraine attacks from tension/cluster headaches

7. Subjects on prophylactic migraine medication are permitted to remain on 1
medication with possible migraine-prophylactic effects if the dose has been
stable for at least 3 months prior to the Screening Visit, and the dose is not
expected to change during the course of the study.

Exclusion Criteria:

2. Subject with a history of HIV disease

3. Subject history with current evidence of uncontrolled, unstable or recently diagnosed
cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and
cerebral ischemia. Subjects with Myocardial Infarction (MI), Acute Coronary Syndrome
(ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient
ischemic attack (TIA) during the 6 months prior to screening

4. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however
subjects can be included who have stable hypertension and/or diabetes for at least 3
months prior to screening).

5. Subjects with major depressive episode within the last 12 months, major depressive
disorder or any anxiety disorder requiring more than 1 medication for each disorder.
Medications to treat major depressive disorder or an anxiety disorder must have been
at a stable dose for at least 3 months prior to the Screening visit.

6. Subjects with other pain syndromes, psychiatric conditions, dementia, or significant
neurological disorders (other than migraine) that, in the Investigator's opinion,
might interfere with study assessments

7. Subject has a history of gastric, or small intestinal surgery (including Gastric
Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that
causes malabsorption

8. Body mass index ≥ 30 kg/m2

9. Subject has current diagnosis of major depressive disorder requiring treatment with
atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality
disorder

10. History of gallstones or cholecystectomy.

11. The subject has a history or current evidence of any unstable medical conditions
(e.g., history of congenital heart disease or arrhythmia, known or suspected
infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would
expose them to undue risk of a significant adverse event (AE) or interfere with
assessments of safety or efficacy during the course of the trial.
We found this trial at
75
sites
10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
Phone: 402-934-0044
Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
77 West Granada Boulevard
Ormond Beach, Florida 32174
Phone: 386-236-2456
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
Phone: 316-689-6683
?
mi
from
Wichita, KS
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
Phone: 505-848-3773
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Phone: 714-774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Anderson, Indiana 46011
Phone: 765-298-2040
?
mi
from
Anderson, IN
Click here to add this to my saved trials
Ann Arbor, Michigan 48104
Phone: 734-677-6000
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Austin, Texas 78745
Phone: 512-388-5717
?
mi
from
Austin, TX
Click here to add this to my saved trials
Bellevue, Washington 98007
Phone: 425-453-0404
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
Berlin, New Jersey
Phone: 856-753-7335
?
mi
from
Berlin, NJ
Click here to add this to my saved trials
3800 Houma Boulevard
Biloxi, Mississippi 39531
Phone: 228-206-1283
?
mi
from
Biloxi, MS
Click here to add this to my saved trials
Boise, Idaho 83704
Phone: 208-685-0600
?
mi
from
Boise, ID
Click here to add this to my saved trials
Boston, Massachusetts 02135
Phone: 617-477-4868
?
mi
from
Boston, MA
Click here to add this to my saved trials
Chalmette, Louisiana 70043
Phone: 203-914-1903
?
mi
from
Chalmette, LA
Click here to add this to my saved trials
Charlottesville, Virginia 22911
Phone: 434-817-2442
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chicago, Illinois 60607
Phone: 312-431-6780
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45215
Phone: 937-912-4444
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Dakota Dunes, South Dakota 57049
Phone: 605-232-9000
?
mi
from
Dakota Dunes, SD
Click here to add this to my saved trials
Dallas, Texas 75231
Phone: 214-369-2600
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dayton, Ohio 45432
Phone: 937-912-4444
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Dayton, Ohio 45459
Phone: 937-224-8200
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Decatur, Georgia 30030
Phone: 404-537-1281
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Dublin, Ohio 43016
Phone: 763-767-4409
?
mi
from
Dublin, OH
Click here to add this to my saved trials
Edgewater, Florida 32132
Phone: 386-428-7730
?
mi
from
Edgewater, FL
Click here to add this to my saved trials
Fort Worth, Texas 76104
Phone: 817-348-0228
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
Phone: 616-940-3504
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Greensboro, North Carolina 27408
Phone: 336-574-8020
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Houston, Texas
Phone: 713-838-2022
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77024
Phone: 346-704-7660
?
mi
from
Houston, TX
Click here to add this to my saved trials
Kansas City, Missouri 64114
Phone: 816-943-0770
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Kenosha, Wisconsin 53142
Phone: 262-925-1280
?
mi
from
Kenosha, WI
Click here to add this to my saved trials
Knoxville, Tennessee 37920
Phone: 865-305-9100
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
La Mesa, California 91942
Phone: 619-567-1550
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
4551 U.S. 90
Lake City, Florida 32055
Phone: 386-438-8977
?
mi
from
Lake City, FL
Click here to add this to my saved trials
Lake Jackson, Texas 77566
Phone: 979-529-9440
?
mi
from
Lake Jackson, TX
Click here to add this to my saved trials
207 West Avenue East
Lampasas, Texas 76550
Phone: 512-556-4130
?
mi
from
Lampasas, TX
Click here to add this to my saved trials
Las Vegas, Nevada 89113
Phone: 702-749-7147
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lemon Grove, California 91945
Phone: 619-303-6130
?
mi
from
Lemon Grove, CA
Click here to add this to my saved trials
640 George Washington Highway
Lincoln, Rhode Island 02865
Phone: 401-305-5200
?
mi
from
Lincoln, RI
Click here to add this to my saved trials
Little Rock, Arkansas 72205
Phone: 501-224-1348
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Long Beach, California 90806
Phone: 866-787-4257
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Manlius, New York 13104
Phone: 315-682-3263
?
mi
from
Manlius, NY
Click here to add this to my saved trials
McLean, Virginia 22102
Phone: 703-288-6931
?
mi
from
McLean, VA
Click here to add this to my saved trials
Miami, Florida 33243
Phone: 305-598-3125
?
mi
from
Miami, FL
Click here to add this to my saved trials
Mount Pleasant, South Carolina 29464
Phone: 843-856-3784
?
mi
from
Mount Pleasant, SC
Click here to add this to my saved trials
New Orleans, Louisiana 70119
Phone: 504-821-8158
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New Orleans, Louisiana 70124
Phone: 504-336-2667
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Newton, Kansas 67114
Phone: 316-804-7304
?
mi
from
Newton, KS
Click here to add this to my saved trials
Norfolk, Nebraska 68701
Phone: 402-371-0797
?
mi
from
Norfolk, NE
Click here to add this to my saved trials
Norman, Oklahoma 73072
Phone: 405-534-5349
?
mi
from
Norman, OK
Click here to add this to my saved trials
465 South Washington Street
North Attleboro, Massachusetts 02760
Phone: 508-316-4268
?
mi
from
North Attleboro, MA
Click here to add this to my saved trials
Oakland, California 94612
Phone: 510-444-2877
?
mi
from
Oakland, CA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19114
Phone: 215-676-6696
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85015
Phone: 602-368-1928
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Plainview, New York 11803
Phone: 516-822-2230
?
mi
from
Plainview, NY
Click here to add this to my saved trials
Portland, Oregon 97210
Phone: 503-972-9827
?
mi
from
Portland, OR
Click here to add this to my saved trials
Prairie Village, Kansas 66206
Phone: 913-381-7180
?
mi
from
Prairie Village, KS
Click here to add this to my saved trials
Raleigh, North Carolina
Phone: 919-783-4895
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Saint Louis, Missouri 63141
Phone: 314-567-3377
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
3862 Mexico Road
Saint Peters, Missouri 63303
Phone: 636-387-5100
?
mi
from
Saint Peters, MO
Click here to add this to my saved trials
Salem, Oregon 97301
Phone: 503-540-0100
?
mi
from
Salem, OR
Click here to add this to my saved trials
Salt Lake City, Utah 84107
Phone: 801-288-0607
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78229
Phone: 346-704-7660
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Francisco, California 94102
Phone: 415-423-4055
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Santa Monica, California 90404
Phone: 310-315-1456
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Seattle, Washington 98105
Phone: 206-522-3330
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Sherman Oaks, California 91403
Phone: 818-990-2671
?
mi
from
Sherman Oaks, CA
Click here to add this to my saved trials
Springfield, Missouri 65807
Phone: 417-841-3626
?
mi
from
Springfield, MO
Click here to add this to my saved trials
Stamford, Connecticut 06905
Phone: 203-914-1903
?
mi
from
Stamford, CT
Click here to add this to my saved trials
Tomball, Texas 77375
Phone: 281-517-0550
?
mi
from
Tomball, TX
Click here to add this to my saved trials
Tucson, Arizona 85710
Phone: 520-829-7502
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Virginia Beach, Virginia 23454
Phone: 757-233-9280
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
Wauconda, Illinois 60084
Phone: 847-526-2151
?
mi
from
Wauconda, IL
Click here to add this to my saved trials
West Palm Beach, Florida 33407
Phone: 561-296-3820
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
Williamsville, New York 14221
Phone: 716-626-6320
?
mi
from
Williamsville, NY
Click here to add this to my saved trials